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Mr Peter Dunlevy, Executive Support
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

19 October 1998

Dear Mr Dunlevy,

Thank you for your letter of 16 October, ref OG 98/64. I appreciate what you say about answering my letter of 30 September. I accept you may not be able to answer fully within the target response time, and confirm we will pay the MCA's reasonable charges for a reasonable response. Here, I note your delicate point about assessing possible charges after "taking account of previous correspondence", and would like to comment on it.

1. No purpose would be served by your repeating anything previously communicated. However, I don't see this as a problem because very little has been communicated so far.

2. The key questions in my letter of 30 September are those numbered 1 to 3. These ask if the MCA has, in fact, carried out any serious evaluation of the risks my paper described. I very much doubt it, but would like to be convinced I'm wrong. The only evidence I have suggests that the MCA simply circulated my paper, under a covering note which indicated little grasp of the issues, and which made no reference to any of the risk factors identified in my questions 6 to 22. Clearly, the simplest way of answering these questions would be to provide me with a copy of any risk assessment prepared by the MCA. This would immediately indicate whether or not those matters were addressed.

3. In relation to questions numbered 6 to 22, in particular, I suppose it is possible that the MCA might claim to have evaluated a specific risk factor, but not be prepared to release documentary evidence to prove it. If so, perhaps you could simply indicate in each case "Evaluated, but not disclosable" - as opposed to "Not evaluated", to signify that the risk assessment did not address some particular point.

4. I hope you and your colleagues appreciate why I enumerated the possible risk factors listed in questions 6 to 22 - apart from trying to formulate questions to fit the Code of Practice on disclosure. The underlying reason is the fear that the authorities depend excessively on pharmacovigilance systems as a means of establishing the 'safety' of medicines in the post-marketing phase. However useful the Yellow Card and related systems may be in some areas, they have obvious limitations in relation to a problem of this kind. Therefore I am looking for evidence that the MCA has gone beyond pharmacovigilance - pretty much an inertia-driven system - in trying to assess what risks there actually are.

Thank you for explaining the origin of Ms Belchem's letter; no problem, I'm glad it's resolved. I am concerned, however, that I never received Dr Jones letter of 18 September, but thank you for sending me the copy. He does have a way with words, doesn't he.

There is no need to acknowledge or reply to this.

Yours sincerely,
Charles Medawar


Contents page
List of correspondence with MCA/CSM